MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. DREAMSTATION CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DREAMSTATION 1

Device Problems Nonstandard Device (1420); Shipping Damage or Problem (1570)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/22/2022

Event Type  malfunction  

Event Description

Philips respironics has a large open recall on the dreamstation cpap machine.I have a unit affected by the recall.Philips shipped my replacement device to the wrong address, even after i called them on the phone to confirm the correct address before shipping.Philips refuses to expedite another machine to me after waiting more than a year and a half.Instead, they want me to wait another 1-2 years for a replacement by adding me to the end of the queue.This is absolutely unacceptable.They screwed up.I demand a new device be sent to me immediately, at the correct address.

• Brand Name: DREAMSTATION CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 16077427
• MDR Text Key: 306526083
• Report Number: MW5114087
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DREAMSTATION 1
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/29/2022
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White